The purpose of this investigation, using hardcopy film, is to compare the accuracy of the Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of breast cancer among women undergoing screening or diagnostic mammography.

Per the new FDA Guidance document for FFDM, accuracy in comparison to Screen-film is no longer required.

6 mammography image sets (4 images per set) from women participating in the study were read and rated (pass/fail) by 2 MQSA (Mammorgraphy Quality Standards Act) certified mammography readers. A typical MQSA evaluation was performed on each image set and an image set was scored Pass or Fail. A total of 12 scores (6 image sets, 2 readers) were obtained.

The proposed research study is a prospective enriched reader trial in which patients who meet the study's eligibility criteria, subject to certain constraints specified in this protocol, will undergo both SF and the investigational Philips FFDM mammography. Two to five sites will participate as image acquisition centers. Images will be read by 9 mammographers reading the SF and Philips FFDM acquired images at various locations under the supervision of study managers.

Per the new FDA Guidance document for FFDM (Class II Special Controls Guidance Document: Full-Field Digital Mammography System), there is no longer a requirement for screen film images for a comparison and a reader study to determine accuracy is not required. 10 images acquired under protocols 2008-002a, 2010-002a and a European site will be read in a MQSA type study. This record has been modified to support the new FDA Guidance document.

The reviewers will evaluate the cases, using soft copy and hard copy images, noting the mammographic attributes for each case and documenting the findings on a clinical image evaluation form, which is very similar to what is used for MQSA Accreditation.

The following attributes will be assessed: in order to provide an overall assessment of whether these image sets collectively are of sufficient acceptable quality for mammography:

Artifacts due to image processing, detector failure and other factors external to the breast on hard-copy and soft-copy displays; and

Overall clinical image quality

Eligibility

Ages Eligible for Study:

40 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Screening and diagnostic mammography patients

Criteria

Inclusion Criteria:

Patient underwent or is scheduled to undergo a screening or diagnostic mammogram examination (right and left craniocaudal and mediolateral oblique with or without special views) at one of the acquisition centers during the course of this research study.

At least 40 years of age

Provides written informed consent indicating willingness to participate in this research study prior to performance of the Philips FFDM mammogram

Meets none of the exclusion criteria

Exclusion Criteria:

Presence of a breast implant,

Patients undergoing a unilateral mammogram or an incomplete SF mammogram

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999596